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Prophylactic administration of intravenous Paracetamol for control of shivering during and post cesarean section with spinal anesthesia

Prophylactic administration of intravenous Paracetamol for control of shivering during and post cesarean section with spinal anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015080710765N7
Enrollment
100
Registered
2015-09-15
Start date
2015-08-08
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Intra and post spinal anesthesia shivering. Condition 2: complications of anaesthesia. Hypothermia, not associated with low enviromental temperature Other complications of anesthesia

Interventions

Intervention 1: Intervention group: in this group paracetamol 1000mg in 100 cc normal saline was infused during 15 -20 min after neonatal delivery for prevention of intra and post-operative shiverin
Treatment - Drugs
Placebo
Intervention group: in this group paracetamol 1000mg in 100 cc normal saline was infused during 15 -20 min after neonatal delivery for prevention of intra and post-operative shivering .
Control group: in this group normal saline iv in same volume intervention group was infused as placebo at 15-20 min after neonatal delivery .

Sponsors

Vice chancellor for Research, Tabriz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pregnant womenaged between 16 to 45 years old candidate for elective cesarean section with spinal anesthesia; ASA physical class I or II with informed consent for spinal anesthesia. Exclusion criteria: patients with ASA physical class III or higher; contraindication for administration of NSAIDS and paracetamol; peptic ulcer; coagulopathy; renal failure;hepatic failure; fever; any contraindication for performing spinal anesthesia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of perioperative and postoperative shivering. Timepoint: In recovery every 15 minutes until discharge from recovery. Method of measurement: Crossly and Mahjon five-point scoring system.;Incidence of intra and post spinal anesthesia shivering. Timepoint: During of surgery and in the recovery room. Method of measurement: visual.

Secondary

MeasureTime frame
Need to drug for treatment of shivering. Timepoint: During surgery and in recovery room. Method of measurement: Dose of drug.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSousan Rasouli

Tabtiz University of Medical Sciences

rasooli_s@yahoo.com+98 41 3553 9161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026